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Compliance aid basics

Solicitor Noel Wardle looks at whether pharmacies have to provide medicines in compliance aids, and whether they can charge for them

The Equality Act (which replaced the Disability Discrimination Act in 2010) is often cited as a reason for supplying medicines in a compliance aid. This complex piece of legislation, in essence, places a statutory duty on businesses to make ‘reasonable adjustments’ in relation to the service they provide to take into account any relevant disability of a service user. This statutory obligation might include the provision of a compliance aid where a patient would be at a ‘substantial disadvantage’ without it. However, the need to provide medicines in a compliance aid under the Equality Act is a balancing exercise.

The NHS Terms of Service for community pharmacies in England state that medicines should be provided in original packs save in certain circumstances, which include because of patient need. The General Pharmaceutical Council (GPhC) has not published specific guidance in relation to the supply of medicines in compliance aids versus original packs, although its Standards require patient-centred care and state that a pharmacist must “give the person all relevant information in a way they can understand, so they can make informed decisions and choices”.

There is, of course, a significant amount of information included with original medicine packs, at least some of which is lost when medicines are put into compliance aids. Additionally, the GPhC provides that pharmacists must ensure “the way in which pharmacy services, including the management of medicines and medical devices, are delivered safeguards the health, safety and wellbeing of patients and the public”. 

We have dealt with many fitness to practise investigations that have centred on the provision of medicines in compliance aids. Recent examples include:

  • Supplying warfarin in monitored dosage system (MDS) trays
  • Dispensing errors not spotted during the final accuracy check, in part because the medicine had been removed from its original pack
  • Dispensing from the previous medicine administration record (MAR) sheet or the patient medication record (PMR) rather than a repeat prescription, due to delays in receiving repeat prescriptions from the surgery
  • Changes in repeat medication not identified when the MDS tray was being prepared
  • Inserting other items into MDS trays outside of the regular prescription
  • Prescriptions being generated more often than required and being submitted for payment even though they were not dispensed

January 2009 NICE guidance Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence provides that non-adherence can arise in two sets of circumstances: intentionally as a result of beliefs and concerns or problems about a medicine, and unintentionally because of practical problems in taking it (e.g. an inability to use an inhaler). 

The guidance suggests no specific intervention can be recommended for all patients, but interventions should be tailored, adding: 

  • Find out what form of support a patient would prefer to increase their adherence 
  • Address any beliefs and concerns patients have that result in reduced adherence
  • Side effects can be a problem for some patients. If this is the case, discuss them
  • Ask patients if prescription charges are a problem for them
  • Because evidence supporting interventions to increase adherence is inconclusive, only use interventions to overcome practical problems associated with non-adherence if a specific need is identified. 

It suggests interventions should be targeted to the need identified. They could include: suggesting patients record their medicine-taking, encouraging patients to monitor their condition, simplifying the dosing regimen, using alternative packaging for the medicine, and using a multi-compartment medicines system (MCA). Compliance aids come towards the end of this list and are not, therefore, the first line solution.

RPS GUIDANCE

The Royal Pharmaceutical Society (RPS) produced guidance (Improving patient outcomes through MCA) and a toolkit in July 2013. This provides that although MCAs may help some patients, evidence indicates they should not automatically be the intervention of choice for all. It says not all medicines are suitable for inclusion in MCAs, and stakeholders should recognise that repackaging it may be unlicensed and involves risks and responsibility for the decisions made.

The RPS recommends using original packs of medicines, supported by appropriate pharmaceutical care, as the preferred intervention in the absence of a specific need for an MCA. Pharmacy owners should therefore carefully consider whether to supply a compliance aid based on the individual needs of patients. The use of a compliance aid to assist with non-adherence requires a balancing exercise and is unlikely to be the first line intervention. 

Compliance aids must be provided free of charge if they are required in order to meet the statutory obligations contained within the Equality Act. In all other circumstances, pharmacy owners may charge for the provision of medicines in a compliance aid. 

The above is a general overview and we recommend that independent legal advice is sought for your specific concerns.

Noel Wardle is partner and head of the regulation team at Charles Russell Speechlys LLP Noel.Wardle@crsblaw.com




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